NCT01423513

Brief Summary

The purpose of this study is to examine the effects of ankle taping on improving muscle function and ankle motion in individuals who frequently twist (sprain) their ankle. It is thought that ankle taping may increase muscle function and ankle motion which would benefit individuals who frequently sprain their ankle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 4, 2016

Status Verified

April 1, 2012

Enrollment Period

1 year

First QC Date

August 22, 2011

Last Update Submit

March 3, 2016

Conditions

Ankle Sprain

Keywords

ankle tapeHoffmann reflexBalance

Outcome Measures

Primary Outcomes (3)

  • Changes in muscle activation

    To determine the changes in muscle activation of the fibularis longus and soleus muscles following a fibular taping or sham taping intervention in individuals with CAI. Changes in muscle activation will be quantified by assessing the H-reflex technique before and after intervention. Hypothesis: We hypothesize that the fibular taping intervention will result in a greater activation of the fibularis longus and soleus muscles than a sham taping intervention.

    All study visits up to day 7

  • Changes in ankle dorsiflexion range of motion (ROM)

    To determine the changes in ankle dorsiflexion ROM following a fibular taping or sham taping intervention in individuals with CAI. Changes in ankle dorsiflexion ROM will be quantified using a weight bearing lunge. Hypothesis: We hypothesize that the fibular taping intervention will result in a greater improvement in ankle dorsiflexion ROM than the sham taping intervention.

    All study visits up to day 7

  • Changes in dynamic balance

    To determine the acute changes in balance following a fibular taping or sham taping intervention in individuals with CAI. Changes in balance will be quantified using the the Star Excursion Balance Test (SEBT). Hypothesis: We hypothesize that the fibular taping intervention will result in greater improvements in reach distance in all three SEBT directions compared to the sham taping intervention.

    All study visits up to day 7

Study Arms (2)

Fibular Taping

EXPERIMENTAL

With the ankle in a neutral position, two strips of nonrigid hypoallergenic tape will be applied beginning at the distal aspect of the fibula, wrapping around the posterior aspect of the leg, and finishing superior and medial to the starting point. Next,a strip of rigid zinc oxide tape will be applied to the distal aspect of the fibula with tension.

Other: Fibular Taping

Sham Taping

SHAM COMPARATOR

Sham taping will be applied in the same manner as the fibular taping, but tension will not applied to the zinc oxide tape

Other: Sham Taping

Interventions

Fibular TapingOTHER

Tape with be applied with tension.

Fibular Taping
Sham TapingOTHER

Tape will be applied without tension

Sham Taping

Eligibility Criteria

Age16 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 16-45 years
  • History of one or more ankle sprains
  • Scoring at least an 85% on the Foot and Ankle Ability Measure (FAAM) Sport or at least 3 on the Modified Ankle Instability Instrument (AII).
  • At least 5° ankle dorsiflexion asymmetry compared to the contralateral limb OR ankle dorsiflexion ROM less than 21°

You may not qualify if:

  • Lower extremity injury or surgery within the past 6 months (including lateral ankle sprain)
  • Diagnosed ankle osteoarthritis
  • History of ankle surgery that involves intra-articular fixation
  • Potential for current pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton University

Omaha, Nebraska, 68178, United States

Location

Related Publications (1)

  • Grindstaff TL, Hanish MJ, Wheeler TJ, Basnett CR, Miriovsky DJ, Danielson EL, Barr JB, Joseph Threlkeld A. Fibular taping does not alter lower extremity spinal reflex excitability in individuals with chronic ankle instability. J Electromyogr Kinesiol. 2015 Apr;25(2):253-9. doi: 10.1016/j.jelekin.2015.01.009. Epub 2015 Feb 16.

    PMID: 25727519DERIVED

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2011

First Posted

August 26, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

March 4, 2016

Record last verified: 2012-04

Locations

US(1)